Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov)

Title: Claude D. Pepper Older Americans Independence Centers (OAICs) (P30)  

Announcement Type
This is a reissue of RFA-AG-10-003

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AG-11-002

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date:  July 21, 2010
Letters of Intent Receipt Date: September 21, 2010
Application Receipt Date: October 21, 2010  
Peer Review Date(s): February/March 2011
Council Review Date: May, 2011
Earliest Anticipated Start Date: July 1, 2011
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: October 22, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The Claude D. Pepper Older American Independence Centers (OAIC) program was established in honor of the late Representative to establish “centers of excellence” in research and training that will increase scientific knowledge leading to better ways to maintain or restore independence in older persons.

The OAIC awards are designed to develop or strengthen awardee institutions’ programs that focus and sustain progress on a key area in aging research. Each area of focus is one in which progress could contribute to greater independence for older persons and offer opportunities for training and career development in aging research. NIA's expectation is that an OAIC, in a given area of focus, will:

Area of Focus

To achieve the objectives listed above, each OAIC should promote a sustained research program in an area of focus through which the center will accomplish the innovation, leadership, collaborative, and career development functions described above.  It is crucial to the design of an OAIC to identify one or more important research areas to be addressed, to specify the goals to be achieved within the five-year OAIC award period, and to provide a plan to reach these goals and a method to evaluate progress toward these goals during the course of the OAIC award. The selection of Core activities (see below) should follow from these considerations.

An OAIC may select an area of research focus from a broad range of topics, including but not limited to:

An OAIC may define its selected area of focus. In general, each research focus described above has the need (and/or the potential) for a wide range of developmental and infrastructural activities that are likely to be interdependent and synergistic. Thus an OAIC strategy of selecting several key activities that address its area of focus may have unique benefits.

Since the level of funding for individual OAICs is unlikely to allow such a set of activities for more than one focus area, applicants are strongly encouraged to select an area in which their strengths allow their OAIC to fulfill NIA's goal for the OAIC program and to direct their proposed OAIC activities toward that research area. The total impact of an OAIC's activities on progress in the selected field(s) should be a major criterion in selection of the focus area and will be a major criterion in peer review and program evaluation.

To capitalize on important new research opportunities or to address unexpected needs for career development support within their institutions, OAICs may also support a limited amount of activity in their cores on topics other than those in their area(s) of focus (see below). Applicants who anticipate providing such support should propose a system for identifying these opportunities and needs and for selecting core activities to address them.

Cognition and Behavioral Science Research as an Area of Focus:  An OAIC application should not include major foci on cognition or behavioral and social sciences, as these are more appropriate for other NIA programs that also use the Center mechanism. However, OAICs are encouraged to support a multidisciplinary approach that includes research in these areas as they relate to the theme or focus of the OIAC.

Health Services Research as an Area of Focus: Research to determine effects of health practices or services, or the use of new or different types of health care providers or interventions, is generally appropriate for a Pepper Center component if the services or interventions follow a defined algorithm and are delivered to or directly involve the individual patient. Additional information about NIA’s policy on health services research within the OAICs can be found on the NIA website (see http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/GeriatricsAndClinicalGerontology/PepperPolicy.htm ).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the P30 award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The estimated amount of funds available to be awarded as a result of this announcement is approximately $3.3 million in fiscal year 2011 for support of three new or renewal Centers and $1.1 million in fiscal year 2012 for support of one new or renewal Center. The maximum allowable direct cost that may be requested is $800,000 per year. An applicant may request a project period of up to 5 years. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Each applicant organization may submit one application.

Resubmissions.  Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).  

Renewals. Renewal applications are permitted in response to this FOA.   

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: September 21, 2010
Application Receipt Date: October 21, 2010
Peer Review Date(s): February/March 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: July 1, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Evan Hadley, M.D.
Director, Division of Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue, 3C307
Bethesda, MD 20892-9205
Phone: (301) 435-3044
FAX: (301) 402-1784
Email: ehadley@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Ramesh Vemuri, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging 
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892
Telephone: (301) 496-9666
FAX:  (301) 402-0066
Email: vemuri@nia.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements below.

Summary of the OAIC

All Cores

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

SPECIFIC INSTRUCTIONS FOR PREPARING THE OAIC APPLICATION

More information about specific application details can be found on the NIA website at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/GeriatricsAndClinicalGerontology/PepperCenterRFA

I.  General Information for the Entire Application

A.    Face Page.  Use PHS 398 Form Page 1. For Item 2, check YES and cite the OAIC FOA number and title. 

B.    Project Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, and Other Significant Contributors, and Human Embryonic Stem Cells. Use PHS 398 Form Page 2 and 2-continued.  The Project Summary serves as a brief overview of the entire application and summarizes the general plan and goals for the proposed OAIC. The listing of project/performance sites should include the applicant institution and all other institutions collaborating via consortium or contractual arrangements.

C.    Table of Contents.  Applicants are discouraged from using PHS 398 Form Page 3, as this is intended for single projects. Instead, due to the complexity of OAIC applications, applicants are strongly encouraged to use the recommended format provided on the NIA website and to number all pages consecutively.

D.    Budget.  Use PHS 398 Form Page 4 and Form Page 5 to provide budget information listed in the recommended Table of Contents.  To aid in the review of the application, insert consolidated budget tables (Table IA for the first year and Table IB for the entire project period – see recommended formats on the NIA website). Place detailed budgets for individual Cores with the corresponding Cores sections, as in the recommended format for the "Table of Contents."  Justify all items carefully according to PHS 398 instructions.

For Consortium/Contractual Arrangements, include the following additional budget information:

E.    Biographical Sketches.  NIA staff will use the information in the biosketch to identify all personnel involved in the proposed OAIC and their institutional appointments. (That information is necessary to identify which possible reviewers may be in conflict with the application.) Also reviewers will use the biosketch to assess the qualifications of key personnel for their roles in the  proposed OAIC (the “Investigators” criterion in the central review criteria). These two functions determine how the biosketches should be presented in the application:

1.     Information for staff assessment of possible reviewer conflicts

Include for all Key Personnel and Other Significant Contributors a biographical sketch with the educational block at the top of the format page completed and Section B, Positions and Honors completed. List the principal investigator/program director first and then other personnel biosketches in alphabetical order. Do not include Sections A (Personal Statement), C (Selected peer-reviewed publications or manuscripts in press), or D (Research Support) in this part of the application. (See 2. below for where to place this information.) However, do include reference to the part(s) of the application and page numbers where complete biographical sketches for each individual are located.

To aid in the review of the application, also insert a completed Table II: “Distribution of Professional Effort on this Application” using the recommended format on the NIA website.

2.     Information for reviewer assessment of personnel qualifications for roles on project.

Following the instructions in the most recent PHS 398 form, complete full Biographical Sketches for Key Personnel and Other Significant Contributors in the part(s) of the application (Cores) where each individual contributes. When someone has a role in more than one part of the application then a complete biosketch for that person should be placed in each section where the individual has a role. As the particular qualifications for roles may differ among Cores, the selected publications and the description of qualifications for the individual may differ among the multiple Biographical Sketches as needed.

F.    Resources.  Applicants should complete separate Resources pages for all Cores. Reviewers will use information from the Resources page of the Leadership and Administrative Core (LAC) to evaluate the quality of the overall environment for the proposed OAIC. 

II. Summary of the OAIC

Present a succinct plan for the entire application. Refer to the recommended format for the Table of Contents on the NIA website to include the information requested below:

A.    Introduction (1 page). For resubmission applications ONLY.

Provide an overview of major changes in the application. If Cores have been deleted or added indicate that here and explain the changes under Significance (below).

B.    Specific Aims (1 page). Describe the goals to be achieved by the OAIC, including:

C.    Research Strategy

Note: Items 1, 2, and 3 are limited to 6 pages in total.

1.     Significance. Focusing on the OAIC as a whole, address (i) the importance of the problem or critical barrier to progress in the field that the proposed OAIC addresses, (ii) how the proposed OAIC will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. For renewals or resubmissions, include the following additional information:

2.     Innovation. Considering the OAIC as a whole, show how the proposed OAIC seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Are these concepts, approaches, methodologies, instrumentation, or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?

3.     Approach. Present the OAIC's overall strategy for serving as a sustained resource to the research program in its selected area(s). Describe how it will accomplish the innovation, intellectual leadership, translational, interdisciplinary, collaborative, and career development functions expected of an OAIC. Describe the specific activities that the OAIC will undertake to accomplish the goals and strategy described above, including how the different components of the OAIC will interact to help accomplish them, how the approaches of the Cores complement each other or are inter-dependent, the mechanisms to ensure coherence of the Center and maintainenance of an interdisciplinary focus, and the mechanisms to be used in assessing progress toward the OAIC's goals.  Where appropriate, provide timelines and organizational charts.  Note the major OAIC Cores and other activities, referencing appropriate subsequent sections of this application that contain more detail.

For renewals, describe findings (with citations) from the prior period of support that are of particular significance to the OAIC as a whole. If Cores included in the prior period of support are not part of the current submission, describe their progress and explain why they are not included. Identify and justify any substantive differences in approaches from the prior period of support.

  1. Additional Information. Discuss the interrelationship of the OAIC to other activities in the applicant's institution (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation (a chart or diagram to demonstrate the relationship may be used). In addition, describe the administrative relationships of the proposed OAIC to the institution. Include relevant issues relating to institutional commitment and settings. Renewal applications from existing OAIC sites may use this section to present summary tables of OAIC activities (such as those prepared for the mid-cycle review). Do not use this section to discuss or expand on information that belongs elsewhere in the application.

D.    Other Elements

Follow PHS 398 instructions (section 5.5), in addition to any further instructions below, to describe the following additional elements of the OAIC as a whole:

  1. Inclusion Enrollment Report (Renewal applications only)
  2. Bibliography and References Cited / Progress Report Publication List. 
  3. Protection of Human Subjects. Describe fully the general principles and policies that will apply to human subjects for the OAIC as a whole.  List all components of the application that involve human subjects and page numbers for the relevant human subjects sections. Include in the appendix all consent forms for human subjects research which apply to developmental projects or pilot/exploratory studies.
  4. Inclusion of Women and Minorities. Describe general principles and policies pertaining to inclusion of women and minority study subjects in the OAIC as a whole.
  5. Inclusion of Children.
  6. Vertebrate Animals.  Approval must be by each individual protocol for projects not having approval elsewhere. List the components in the application that involve vertebrate animals and page numbers for the relevant vertebrate animal sections.
  7. Select Agent Research.
  8. Consortium/Contractual Arrangements. Before submitting an application that contains a consortium arrangement, the applicant institution and each collaborating institution should reach agreement on the scientific, administrative, financial, and reporting requirements for the grant. Include the following statement, accompanied by signatures of the appropriate administrative officials, from each of the collaborating institutions: "The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter-institutional agreement(s) consistent with that policy." Include this information here and/or with individual Cores, as appropriate.
  9. Letters of Support. Place Institutional letters of support for the OAIC in this section.
  10.  Table III: Percentage Distribution of Resource Cores to OAIC- and Externally Funded Research Projects. Use the recommended format for this information on the NIA website.
  11. All Personnel Report (Renewal applications only).

III. OAIC Core Structure

To accomplish the program goals, each OAIC award will provide support for the following components and activities:

1) A Leadership and Administrative Core (LAC) (required)
2) A Research Career Development Core (RCDC) (required)
3) One or more Resource Cores (RCs) (required)
4) A Pilot/Exploratory Studies Core (PESC) (optional)

5) An Information Dissemination Core (optional)

The Leadership and Administrative Core (LAC) will support research planning and evaluation activities for the Cores, the OAIC as a whole, and other administrative activities.

The Research Career Development Core (RCDC) will support career development activities and infrastructure, including salary, fringe benefits, travel, and didactic training for junior faculty who are conducting pilot studies, developmental projects or working on independently funded projects.

An OAIC may provide support to a variety of types of research in its area(s) of focus: a) testing of prevention, intervention, diagnostic, or functional assessment techniques; b) translational research (including mechanistic studies), experimental therapeutic studies in laboratory animals, studies in animal models, and c) technology or methods development research.

Resource Cores (RCs) will provide resources to (a) enhance or support projects funded primarily by other mechanisms, and (b) develop and validate model systems (e.g., animal models), methods, assays, analytic techniques, and equipment, as well as diagnostic, assessment and survey instruments to advance aging research.

A Pilot/Exploratory Studies Core (PESC) is optional. The PESC supports pilot or exploratory research to acquire information needed to select or design future crucial studies in the OAIC area of focus.

Each OAIC must support a significant amount of clinical research with human subjects; however, every core within an OAIC is not required to support studies on human subjects. Core support may be provided for basic and translational research in animal models and in vitro systems and for secondary data set analyses. 

While most of the research supported by RCs, the PESC and the RCDC should relate to the areas selected as the OAIC research theme(s), a limited amount of support in these Cores is acceptable for topics in other areas of aging research related to the goals of the NIA OAIC program, as noted above.

An Information Dissemination Core (IDC) is optional. OAICs may request support for a core to disseminate information relating to their research areas and/or to enhance translation of clinical research findings into health care practice.

A. LEADERSHIP AND ADMINISTRATIVE CORE (LAC)

The Leadership and Administrative Core (LAC) will provide support for planning, organizational, evaluation, and administrative activities relating to the other Cores and to the OAIC as a whole. The Principal Investigator for the OAIC application should be the Core Leader for the LAC. He/she should have sufficient expertise in the OAIC's area of research focus to exercise effective scientific judgment and leadership.

The LAC is responsible for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals of the OAIC. Specifically, the LAC should conduct or organize the following activities:

The LAC may elect to convene a single panel or separate panels to conduct reviews of the above activities. Panels may meet in person or by teleconference. At least one third of the members of each panel should be external to the awardee institution. Ad hoc reviewers may be invited to participate in the panels to address specific projects in their areas of expertise.

Additionally, active involvement of the LAC is required in the following activities:

  1. Yearly review of progress toward the OAIC goals by an Advisory Board external to the awardee institution. Members of the External Advisory Board (EAB) are selected by the OAIC subject to approval by NIA.   The names of potential advisory board members should not be included in the application and potential members should not be contacted until after the award; however, the operating procedures of  the EAB, including the frequency of its meetings and the methods for the identification of members should be specified.   A report of the annual review by this Board should be included in annual Progress Reports.
  2. Preparation of information for a progress review by an advisory panel selected and convened by NIA, at or shortly following the conclusion of the second year of the OAIC award. This Mid-Cycle Review will evaluate individual OAICs that have reached the midpoint of their funding periods and advise NIA on the progress and direction of the OAIC Program in general.
  3. Preparation of administrative documents relating to the award.

Additional activities for which the LAC may provide support include:

Participation of OAIC investigators and Coordinating Unit leadership at an annual scientific meeting is mandatory. Participants will include the PD/PI, Center Administrator, Core Leaders and others, as appropriate for purposes of programmatic coordination and scientific exchange. Applications must include budget requests for attendance at these meetings as part of the budget for the LAC.

Up to $150,000 in first year direct costs may be requested for LAC activities.

B. RESEARCH CAREER DEVELOPMENT CORE (RCDC)

A Research Career Development Core (RCDC) is a required component of an OAIC. The RCDC should be led by a scientist with experience in research training and a history of successful mentoring. The RCDC Core Leader will be responsible for coordination, oversight, and reporting of the activities described below.

The goal for the RCDC is to promote the development of future research leaders in the OAIC area of focus, particularly leaders who can integrate clinical insights regarding health/disease and independence/disability in old age with knowledge of advances in the basic sciences to improve clinical interventions for maintaining health and independence.

Toward this goal, the RCDC will provide salary and other support for junior faculty and research associates to acquire research skills in the area of OAIC focus. Specifically, the Research Career Development Core will provide support for salary, didactic training, travel, information resources, and secretarial or technical support. Junior faculty and research associates who receive RCDC support may also receive funding for pilot/exploratory studies (see Pilot/Exploratory Studies Core below). Funds for salaries and other expenses of the Core Leader and support staff may be requested.

The career development plans for at least some of the junior faculty and research associates supported through the RCDC should provide for the development of combined competence in basic and clinical research. This should be accomplished either by enhancing the clinical research experience of basic scientists, developing basic research skills and experience of clinical investigators, or providing a combination of the two approaches. An emphasis on development of skills for translating basic findings into clinical research, and clinical findings into mechanistic studies, is encouraged. Regarding the goal of developing researchers with combined expertise in clinical and basic research (including aging research), OAIC applicants should consider the previous training of the individual candidate in determining the nature and extent of didactic training and research activities for which RCDC support is requested.

At least some of the junior faculty and research associates selected for support through the RCDC should hold a clinical doctoral degree. The development of strong aging-related research capabilities in individuals with clinical geriatrics competence, as evidenced by Board certification of qualifications in geriatrics, is a particular program priority. (Such individuals include both those whose sole fellowship training is in geriatrics, as well as those who have received training in both geriatrics and another clinical specialty.) Although the inclusion of such individuals among those receiving RCDC support is not a requirement for OAICs, applicants are strongly encouraged to explore possibilities for recruiting and including such persons, and to coordinate their activities with clinical training programs to encourage the development of individuals with both training in geriatrics and research interests in the OAIC area of focus. OAIC career development support for RCDC-supported junior faculty and research associates should be integrated with other sources of career support that they may be receiving (e.g., NIH "K-series" career development awards, fellowship, non-NIH career awards) in concerted programs for career development.

OAIC applicants should provide a plan for their strategy of recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive RCDC support over the proposed OAIC award period, and describe the abilities they expect recipients of this support to acquire. This plan should include provision for peer review of proposals for provision of RCDC salary support to junior faculty. At least one third of these peer reviewers should be from outside the awardee institution. Special attention should be paid to the recruitment of minority candidates for career development activities. Attention to issues of health disparities is highly valued by the program.

In addition, the OAIC proposal should identify the individuals selected for at least the first year of RCDC support, describe what their activities will be, and delineate the nature of institutional commitments to the individuals' development. A description of mentors' research activities (including a biographical sketch of each mentor) and their commitments in training and supervising these individuals should also be provided. The OAIC goals for the individual's career progression by the end of the OAIC award period should be described. The description should explain how the proposed use of OAIC funds (including funds for pilot/exploratory study funding if this is also proposed for the individual) will contribute to OAIC program goals for research career development in its selected area of research focus.

If any RCDC activities involve human intervention studies funded by the OAIC, NIA staff should receive, prior to their initiation, a description of the study and plans for data and safety monitoring and for notification of clinically significant events to NIA staff. Such plans should be consistent with NIA policy (see http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm). In addition, if an RCDC will support human intervention studies in the future, applications should describe procedures for developing data and safety monitoring plans and notification of NIA staff.

A maximum of $450,000 in first-year direct costs may be requested for the Research Career Development Core.

C. RESOURCE CORES (RCs)

Each Resource Core (RC) should be based on a research field or function that contributes to the OAIC area(s) of focus. These cores may be defined in terms of a biomedical or biotechnology field (e.g., clinical trials, endocrinology, geriatric assessment, bioengineering); a service function (e.g., subject recruitment and retention, pathology, genotyping); or a supply function (e.g., animals). A minimum of one RC is required for an OAIC application.

Innovative organizational approaches are encouraged for each Resource Core proposed. A Core Leader should be named, and plans for the scientific and administrative functioning should be presented. The method for prioritizing access to core resources requested by multiple projects should be described. Salary and other expenses for the core leader and administrative staff may be requested.

In designing RCs, the applicant is strongly encouraged to consider the full range of disciplines, technologies, methodologies, services, and resources that could be applied to the OAIC's selected area(s) of focus. However, there is no requirement that an OAIC Resource Core include this full range. The selection of areas for Resource Cores should be made on the basis of the contribution of services and support to the overall goals of the OAIC. A clear statement of how individual cores will enhance the scientific productivity of the projects and assist the center investigators to realize the OAIC objectives for its area of focus must be provided in each application. The evaluation of the justification for proposed cores by peer reviewers will include consideration of the scientific merit of the core.

Examples of possible RCs include but are not limited to:

RCs may provide services for developmental studies that are part of the RC infrastructure (see below) and for pilot/exploratory studies included in the PESC (see below). RCs should also provide services to enhance and integrate the scientific contributions of basic and/or clinical research projects relevant to the OAIC focus, whose support is independent of the OAIC (e.g., research funded through R01, P01, U01, non-NIH mechanisms). In general, RCs are expected to interact with the studies they support, providing expertise in the design, conduct, and analysis of results as well as technical services or products. Hence, support for professional staff time for such interactions is encouraged where appropriate. Research-related patient care costs are eligible for support though the RCs, but routine patient care costs may not be requested.

There is no limit to the number of proposed Resource Cores; however, applicants should consider the feasibility of supporting multiple RCs within the allowable OAIC budget. An applicant may not propose a Resource Core unless it will support at least two projects. Evaluation of the justification for proposed cores by peer reviewers will include consideration of the scientific merit of the research projects supported by the cores (if they have not previously been reviewed and funded by NIH).. External Projects will be evaluated on the basis of previous peer review and funding source. Developmental Projects within each Resource Core will be evaluated for scientific merit as a part of the OAIC application review process.

Developmental Projects (DPs)

In addition to the support of services to other projects, RCs may directly conduct a limited amount of technology, resource and/or methods development projects. These projects are referred to below as DPs. The goal of these DPs is to establish new methods or technologies that will enrich the resources of the Core or the services it provides.   Developmental studies which challenge existing paradigms or develop new methodologies or technologies are highly valued.

Examples of activities in DPs are listed below. However, this list does not describe the full range of supported activities, nor is it intended to direct applicants towards these areas.

Developmental Projects supported by a RC must relate to the overall goals of the OAIC. A proposed RC may request support of up to $75,000 (direct costs) per year for developmental projects. Specific developmental projects to be conducted by an RC using these funds may last from one to five years. The first year of developmental activities using these funds should be described in detail in the OAIC application, clearly delineating the approach taken for developing and testing the new methods or analytic approaches and discussing how the results will be analyzed. Developmental activities for subsequent years must be reviewed by the OAIC internal and external review mechanisms (see LAC section).

NIA requires that program staff be notified when a developmental grant award is made by an OAIC to its investigators; however, this can be done at the time of the progress report, unless the developmental grant involves a human intervention study funded by the OAIC, in which case a description of the study and plans for data and safety monitoring must be communicated to, and approved by, NIA staff prior to initiation of the study. In addition, if the RC will support developmental projects involving human intervention studies in the future, the application should include a description of procedures for developing data and safety monitoring plans and notification of NIA staff.

D. PILOT/EXPLORATORY STUDIES CORE (PESC)

Inclusion of a PESC is optional. OAICs may conduct Pilot/Exploratory Studies (PESs) to acquire information needed to select or design future crucial studies in the OAIC area of focus. PESs may be categorized as standard PESs or small PESs based on their budgets (described below). These studies may be led by junior faculty and or research associates receiving OAIC RCDC support, or by other senior or junior investigators. A scientist responsible for leadership of this Core must be identified in the OAIC application.

Funding for Pilot/Exploratory Studies (PESs) may be for:

The above examples are not exhaustive of the types of PESs that could be supported.

A maximum of $250,000 in direct first-year costs may be requested for the PESC to support PESs. Applicants may propose up to 5 PESs in the first year. Direct costs should range between $25,000 and $50,000 per year for standard PESs, and $10,000 or less for small PESs. All PESs may not exceed 3 years in duration. Up to $50,000 of the $250,000 budget for the PESC may be devoted to small PESs.

PESs for the first year of the proposal should be included in the OAIC application. The specific aims of each proposed PES must address the relationship of the PES to the overall theme or focus of the OAIC.  Specific aims and research strategy for each proposed PES should be included in this Core. Budgets should be prepared for all 5 years of the OAIC application.

OAIC-supported pilot studies involving human interventions require approval by NIA staff prior to their initiation. Investigators planning to conduct pilot studies involving human interventions must communicate to NIA staff a description of the study and plans for data and safety monitoring and for notification of clinically significant events to NIA staff. Such plans should be consistent with NIA policy (see http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm). Pilot studies that do not involve human interventions do not require advance approval by NIA; however, NIA does require that program staff be notified of such a pilot grant award having been made. This can be done at the time of the progress report (see Section VI.3). In addition, if the PESC will support human intervention studies in the future, the application should include a description of procedures for developing data and safety monitoring plans and notification of NIA staff.

Participating researchers in OAICs are also encouraged to consider seeking additional sources of funding for pilot or exploratory studies, such as the NIH Small Research Grant Program (R03)  (http://grants.nih.gov/grants/guide/pa-files/PA-10-064.html) and NIH Exploratory/Developmental Research Grant Award (R21) (http://grants.nih.gov/grants/guide/pa-files/PA-10-069.html).

E. INFORMATION DISSEMINATION CORE (IDC)

Inclusion of an IDC is optional. OAICs may request support for a core to disseminate information relating to their research areas and/or to enhance translation of clinical research findings into health care practice.  These activities may include communication with professional societies, and private and public organizations responsible for health care of older persons or policies affecting clinical research on older persons. Examples of possible activities include, but are not limited to,  preparation of information and organization of briefings for key health care organizations,  collaborative activities for information exchange among multiple governmental and nongovernmental organizations, and participation in the development of evidence-based practice guidelines by professional societies. A maximum of $60,000 direct costs per year may be requested for this Core. The types of activities planned for the Core, the criteria and process for their selection, and the staffing and organization of the Core and its relation to the Leadership and Administrative Core should be presented.

IV. HOW TO ORGANIZE INDIVIDUAL CORES

Prepare each Core as a separate section that begins on a new page of the application. Continue to number the pages consecutively. Include the Core leader’s name at the upper right-hand corner of each page under the PI’s name.

Each Resource Core (RC) should be numbered sequentially and identified by titles (e.g., Recruitment Core, Biostatistics Core, etc.) and consecutive numbers (RC1, RC2, etc.). Number External Projects and Developmental Projects (DPs) associated with RCs sequentially as EP-1, EP-2, DP-1, DP-2, etc., regardless of the Core to which they are attached.

Following is information describing the organization of each individual Core section, with more specific information particular to each Core, as needed.

D.    Title Page for Individual Core.  Use the recommended Title Page format on the DGCG website.

E.    Project Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, and Other Significant Contributors, and Human Embryonic Stem Cells. Use PHS 398 Form Page 2 and 2-continued.

F.    Budget (PHS 398 Form Page 4 and Form Page 5).  Provide budgets for the first 12-month budget period and for the entire grant period for each Cores (including a detailed budget justification). Future year annual increases are limited to no more than 3%. Detailed guidance specific to each Core follows:

  1. LAC: Support for salary, travel, and other expenses of the LAC Director, Administrator, and appropriate administrative staff may be requested. Support for members of advisory panels to the OAIC to individual Cores (e.g., RCDC, RC, and PESC) should also be requested within the LAC budget. First year direct costs should not exceed $150,000.
    1. Special Requirement: Participation of OAIC investigators at an annual OAIC scientific meeting attended by NIA staff is mandatory.  Participants will include the PD/PI, Center Administrator, Core Leaders, and others, as appropriate for purposes of programmatic coordination and scientific exchange.  Applications must include budget requests for attendance at these meetings as part of the budget for the LAC.
  2. RCDC: First year direct costs are limited to a maximum of $450,000.
  3. RCs: First year direct costs for each proposed RC are limited to a maximum of $75,000. This includes $35,000 (minimum) to $75,000 (maximum) in first year direct costs per Developmental Project. A maximum of two Developmental Projects can be requested as part of each RC. There is no limit to the number of proposed RCs; however, applicants should consider the feasibility of supporting multiple RCs within the OAIC budget limits.
  4. PESC: First year direct costs for the PESC are limited to a maximum of $250,000 to support standard and small Pilot/Exploratory Studies (PESs). Up to 5 PESs may be proposed for the first year. Direct costs should range between $25,000 and $50,000 per year for standard PESs, and $10,000 or less for small PESs. PESs may not exceed 3 years in duration. Up to $50,000 of the $250,000 budget for the PESC may be devoted to small PESs. List the budget for all years of each proposed PES as a line item within the overall PESC budget.
  5. IDC: First year direct costs for the IDC should not exceed $60,000.

G.    Biographical Sketches. Provide a complete Biographical Sketch (PHS 398 parts A – D) for each individual associated with the Core. The Core Leader is considered the Program Director/Prinicpal Investigator of the Core. Biographical Sketches are limited to 4 pages and no more than 15 peer-reviewed publications or manuscripts in press.

For new OAIC applications, prospective advisory committee members should not be named in the application or recruited until after the review is complete (though criteria used to select advisors should be described in the appropriate section of the application). For consultants who are currently employed, or with whom prospective employment has already been discussed, identify them by name and indicate their respective institutions.

Detailed guidance particular to the individual Cores follows:

a.     LAC: As the Principal Investigator of the proposed OAIC should also be the Core Leader of the LAC, his/her Biographical Sketch should  present his/her scientific expertise in the proposed OAIC's area(s) of focus and his/her capacity for the leadership of a center of excellence in aging research. Consultants to the OAIC as a whole should be listed in the LAC section; consultants specific to a particular Core should be listed in the appropriate Core section.

b.     RCDC: Present all personnel involved in the RCDC, including Core Leader, Senior/Key Personnel, potential Mentors, Consultants, other significant Contributors, and all Career Development Candidates. The personal statement section of the Biographical Sketch should outline the planned career development activities for each Career Development Candidate. Mentors should describe their planned activities in support of Career Development Candidates.

c.     RC, PESC, and IDC: Present all personnel involved in the Core, including Core Leader, Senior/Key Personnel, Consultants, and other significant Contributors. Descriptions of  the qualifications of each proposed Core Leader and other personnel relevant to the functions of the Core should be included here.

H.    Resources.  Describe resources and environment that are relevant and/or unique to the individual Core. Note: Reviewers will use information from the Resources page of the LAC to evaluate the quality of the overall environment for the proposed OAIC.

I.      Introduction (1 page). For resubmission applications ONLY. The Introduction should be a summary response to the global concerns expressed about the proposed Core during the previous review.

J.     Specific Aims (1 page)

LAC: Provide an overview of how the LAC particularly will implement the theme of the center.

RCDC: Describe what the intended outcomes and career advancement goals are for RCDC scholars.

RC: Show the intended role of the Resource Core in relation to the Center as a whole and to the theme of the Center. Use this section to summarize the specific aims of each External Project (EP) or Developmental Project (DP). If an EP is supported by more than one OAIC RC, list the External Project in each RC and state the pages in the application where the initial description can be found.

PESC: Outline the topic areas to be solicited and the expected outcome for pilot or exploratory study awards.

IDC: Describe the role of the IDC in enhancing translation of clinical research findings into health care practice.

K.    Research Strategy (6 pages)

Organize the Research Strategy into sections on: a. Significance; and b. Approach.

a. Significance

Up to 1 page is recommended for the Significance section of each Core.

b. Approach

In the guidance below, 5 pages are recommended for the Approach section of each Core.

Note:  New applications should not name potential advisors in the application or select advisors prior to peer review of the OAIC application.

External Projects (EPs). For each EP proposed for Core support during the first year of the OAIC grant, list the PD/PI, title of award, source of award, and duration of external support. In addition, briefly present the approach and any innovative aspects of each EP that has not been presented elsewhere, or otherwise, the pages in the application where the initial description can be found.

Developmental Projects (DPs). Each RC may support a maximum of 2 DPs, each lasting 1-5 years, to explore new technologies, resources, and/or methodologies for application by the RC. For each DP, list the Title, Project Leader and Senior/Key Personnel (including page references to their Biographical Sketches), a description of the approach that the DP will use to achieve its goals, and any innovative aspects. Also describe how DPs will interact with other Core resources of the OAIC.

Pilot/Exploratory Studies (PESs). Up to 5 PESs may be supported for the first year. Number each PES sequentially (e.g., PES-1, PES-2, etc.). For each PES, list the Title, Project Leader and Senior/Key Personnel (including page references to their Biographical Sketches), and a description of the approach that the PES will use to achieve its goals. Describe any innovative aspectives of the PES. Describe how the PES will interact with other Core resources of the OAIC.

L.    Other Elements

Follow PHS 398 instructions (section 5.5), in addition to any further instructions below, to describe the following additional elements specific to each Core or study within the Core:

  1. Inclusion Enrollment Report (Renewal applications only)
  2. Bibliography and References Cited / Progress Report Publication List. 
  3. Protection of Human Subjects. Describe fully the general principles and policies that will apply to human subjects for the OAIC as a whole.  List all components of the application that involve human subjects and page numbers for the relevant human subjects sections. If the application describes specific human intervention studies, then, for each study, describe the plan for data and safety monitoring and notification of NIA staff as consistent with NIA policy (http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm). In addition, if a Core will support human intervention studies currently or in the future, describe procedures for developing data and safety monitoring plans and notification of NIA staff. Include in the appendix all consent forms for human subjects research which apply to developmental projects or pilot/exploratory studies.
  4. Inclusion of Women and Minorities. Describe general principles and policies pertaining to inclusion of women and minority study subjects in the OAIC as a whole.
  5. Inclusion of Children.
  6. Vertebrate Animals.  Approval must be by each individual protocol for projects not having approval elsewhere. List the components in the application that involve vertebrate animals and page numbers for the relevant vertebrate animal sections.
  7. Select Agent Research.
  8. Consortium/Contractual Arrangements. Before submitting an application that contains a consortium arrangement, the applicant institution and each collaborating institution should reach agreement on the scientific, administrative, financial, and reporting requirements for the grant.  Include the following statement, accompanied by signatures of the appropriate administrative officials, from each of the collaborating institutions: "The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter-institutional agreement(s) consistent with that policy." Include this information here and/or in the “Summary of the OAIC” as appropriate.
  9. Letters of Support. Include letters from Senior/Key Personnel, Consultants, and Other Significant Contributors (1 page maximum).

RESUBMISSION

Applicants who responded to OAIC RFAs AG-07-008 and AG-10-003 but did not receive awards may submit resubmission applications in response to this FOA.  One introduction page is allowed at the beginning of Section II (Summary of the OAIC) to outline the response to reviewers’ concerns, and one additional page is allowed in each Core section to address concerns relevant to that Core.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

All appendix materials should be contained within one PDF file no larger than 20 megabytes. The file should be organized into folders in the order of the Cores to which the information relates. Refer to the PHS 398 instructions for guidance on which materials are allowable in the Appendix.

Do not use the Appendix to circumvent the page limitations.  An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Aging and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact of the Proposed OAIC

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

The proposed OAIC will be reviewed both as a whole and by each Core for each of the criteria below. For the OAIC as a whole, reviewers will give numerical impact ratings, but for each Core, reviewers will provide only adjectival descriptors.

OAIC AS A WHOLE

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

The following questions are also considered in evaluating the overall significance of the proposed OAIC:

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

The following questions are also considered in evaluating the investigators of the overall proposed OAIC:

If there are plans to recruit investigator(s), are those plans reasonable and necessary and can those efforts be completed in a timely manner, such that the recruited investigator(s) can make meaningful contributions to the OAIC?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

The following questions are also considered in evaluating the overall innovation of the proposed OAIC:

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

The following questions are also considered in evaluating the overall approach of the proposed OAIC:

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

The following questions are also considered in evaluating the overall environment of the proposed OAIC:

CORES

Each Core will be evaluated according to the following criteria:

Significance

Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

The following questions are also considered in evaluating the significance of each Core:

Investigators

Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

The following questions are also considered in evaluating the investigators of each Core:

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

The following questions are also considered in evaluating the approach of each Core:

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

The following questions are also considered in evaluating the environment of the Core:

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

For renewal applications from existing OAICs, the following questions are also considered:

Revision Applications. .  Revisions are not allowed for this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations. Foreign are not allowed for this FOA.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Evan Hadley, M.D.
Director, Division of Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue, 3C307
Bethesda, MD 20892-9205
Phone: (301) 435-3044
FAX: (301) 402-1784
Email: ehadley@nih.gov

2. Peer Review Contacts:

Ramesh Vemuri, Ph.D.
Chief, Scientific Review Branch
National Institute on Aging 
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892
Telephone: (301) 496-9666
FAX:  (301) 402-0066
Email: vemuri@nia.nih.gov

3. Financial or Grants Management Contacts:

Janis Peterson
Grants and Contracts Management Branch
National Institute on Aging
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 402-7739
FAX:  (301) 402-3672
Email: petersonja@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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